Cost ManagementThe decision to terminate the Phase 3 Lotus trial of FYB206 is expected to save investment costs in the high double-digit million range, showcasing Formycon’s expertise in biosimilar development.
Market PositionThe U.S. FDA has provisionally determined that Otulfi would be interchangeable with the reference drug Stelara, which is a positive development for market penetration.
Regulatory ApprovalThe U.S. FDA has confirmed that the ongoing Phase 1 Dahlia trial combined with a comprehensive analytical program would be sufficient to demonstrate the therapeutic comparability of FYB206 with Keytruda, thus eliminating the need for a Phase 3 trial.